Karɓar Sabon Amfani da Magunguna ga Mai Hana Pan-TRK Zurletrectinib a China

A ranar 15 ga Afrilu, 2025, InnoCare Pharma ta sanar da cewa Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta karɓi Sabuwar Amfani da Magunguna (NDA) don sabon ƙarni na pan-TRK inhibitor zurletrectinib (ICP-723) don maganin manya da matasa (shekaru 12 zuwa 18) waɗanda ke da ciwace-ciwacen da suka yi tsanani waɗanda ke ɗauke da haɗin kwayoyin halitta na NTRK.

Kwayoyin halittar NTRK suna faruwa a cikin nau'ikan ciwon daji na manya da na yara daban-daban. A wasu nau'ikan ciwon daji da ba kasafai ake samu ba, kamar ciwon daji na glandar salivary, ciwon nono na secretory, da kuma fibrosarcoma na jarirai, yawan kamuwa da ciwon daji na NTRK ya wuce kashi 90%[1]. An kiyasta cewa ana gano sabbin kamuwa da cutar NTRK guda 6,500 a kowace shekara a China. Akwai buƙatu na asibiti da ba a cika su ba a wannan fanni saboda rashin ingantattun hanyoyin magani.

Zurletrectinib wani sabon maganin hana TRK ne wanda aka ƙirƙiro kwanan nan wanda ke nuna aiki akan TRK WT da kuma mutant kinases.

Mujallar Burtaniya ta Ciwon daji, wani ɓangare na mujallar kimiyya mai suna Nature, ta buga wata takarda mai taken "Zurletrectinib wani maganin hana TRK ne na zamani wanda ke da ƙarfi a cikin kwakwalwa wanda ke yaƙi da ciwon daji na NTRK wanda ke da juriya ga magungunan ƙarni na farko". Mujallar ta kammala da cewa zurletrectinib wani sabon maganin hana TRK ne mai ƙarfi, wanda ke da ƙarfin shigar kwakwalwa cikin jiki da kuma ƙarfin aikin da ke cikin kwakwalwa fiye da sauran magungunan ƙarni na gaba.

Jaridar ta nuna cewa zurletrectinib ya nuna ƙarfi mai ƙarfi akan kinases na TRKA, TRKB, da TRKC WT, da kuma maye gurbi na juriya da aka samu na TRKA G595R da TRKA G667C. Zurletrectinib ya fi ƙarfin aiki fiye da sauran masu hana TRK na ƙarni na farko da FDA ta amince da su ko kuma waɗanda aka gwada a asibiti (larotrectinib) da kuma na gaba (selitrectinib da repotrectinib) waɗanda suka yi maganin yawancin maye gurbi na juriya na TRK. Hakazalika, zurletrectinib (1 mg/kg BID) ya hana ci gaban ƙari a cikin samfuran xenograft da aka samo daga ƙwayoyin haɗin NTRK masu kyau a kashi sau 30 ƙasa da na selitrectinib.

Takardar ta ƙara nuna cewa, a cikin wani bincike da aka yi kan pharmacokinetic na tsarin jijiyoyi na tsakiya (CNS) a cikin berayen SD, zurletrectinib ya nuna ingantaccen ikon shiga shingen jini-kwakwalwa, yana isa ga kwakwalwa yadda ya kamata fiye da selitrectinib da repotrectinib. Ƙara shigar kwakwalwa ta Zurletrectinib shi ma an fassara shi zuwa ingantaccen aikin hana ƙari. A cikin samfurin glioma xenograft na linzamin kwamfuta mai kama da orthotopic wanda ke ɗauke da maye gurbi na juriya na TRKA G598R/G670A, zurletrectinib (15 mg/kg) ya inganta rayuwar beraye masu ɗauke da gliomas na orthotopic NTRK fusion-positive, TRK-mutant gliomas (tsakanin rayuwa = 41.5, 66.5, da kwanaki 104 don selitrectinib, repotrectinib, da zurletrectinib bi da bi; P < 0.05), yana nuna inganci mafi kyau idan aka kwatanta da repotrectinib (15 mg/kg) da seletrectinib (30 mg/kg) (P=0.0384 da 0.0022, bi da bi), tare da kyakkyawan bayanin aminci.

A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.

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Lokacin Saƙo: Afrilu-17-2025